HHS OIG Paints with Broad Brush in Criticizing Drug Manufacturer Coupon Programs

This post was written by Robert Hill, Carol Loepere, and Joseph Metro

In its September 19, 2014 Special Advisory Bulletin (SAB), the Office of Inspector General (OIG) of the Department of Health & Human Services (HHS) noted the potential risks to federal health care programs presented by pharmaceutical manufacturers’ coupon programs designed to reduce or eliminate patient copayment requirements for brand-name drugs, and emphasized that coupon program sponsors and pharmacies are at risk of sanctions if they fail to take appropriate steps to carve out federal health care program beneficiaries from using the coupons. The OIG points out these coupon programs – which may take different forms, such as print coupons, electronic coupons, debit cards, and direct reimbursements – are remuneration offered to consumers to induce the purchase of specific items, and therefore implicate the criminal federal anti-kickback statute, 42 U.S.C § 1320a-7b(b). Where remuneration is knowingly and willfully paid with the intent to induce or reward referrals of items or services payable by a federal health care program, the anti-kickback statute is violated. The OIG goes on to observe that a claim that includes items or services resulting from a kickback violation would also constitute a false or fraudulent claim under the False Claims Act, 31 U.S.C. § 3729, and grounds for civil money penalties for beneficiary inducement if offer or acceptance of copayment coupons may induce a beneficiary to use a particular practitioner or pharmacy, 42 U.S.C § 1320a-7a(a)(5). While the SAB’s focus is on manufacturer coupon practices, in a footnote, the OIG states that pharmacies accepting coupons for Part D copayments may also be subject to these sanctions.

Notwithstanding the potential benefits of coupon programs to provide access to brand-name drugs and adherence to drug regimens, the OIG claims that such coupon programs may interfere with federal health care program cost-sharing requirements to promote prudent prescribing and purchasing choices by physicians and patients based on the “true costs” of drug and price competition in the market. As a result, the OIG writes, “[w]hile copayment coupons provide an immediate financial benefit to beneficiaries, they ultimately can harm both Federal health care programs and their beneficiaries.”

In the SAB, the OIG acknowledges that the pharmaceutical industry is aware of the potential anti-kickback concerns and generally has implemented a variety of controls to exclude federal health care program beneficiaries from these programs. The OIG’s concern seems to be that these controls don’t go far enough or don’t always work. In other words, the OIG sees the glass as “half empty.” The OIG does not seem to acknowledge that the glass may actually be half-full – i.e., the industry's attempt to have some controls (even if imperfect) evidences manufacturers’ intent to comply with the statute, making it difficult to show criminal liability.

In fact, the OIG’s report, “Manufacturer Safeguards May Not Prevent Copayment Coupon Use for Part D Drugs” (OEI-05-12-00540) http://go.usa.gov/pdYQ, issued concurrently with the SAB, describes in detail mechanisms used by various manufacturers, most notably through claims processing and “switches,” to prevent use of the coupons for drugs paid for by Medicare Part D. The report identifies the principal shortcomings identified with these mechanisms as stemming from the fact that CMS does not permit manufacturers to submit Part D enrollment verification requests (“E1 transactions”) to the Part D Transaction Facilitator because of privacy concerns, so that manufacturers must use various “proxies” to attempt to determine whether the individual using the coupon is enrolled in a Part D plan. The report finds that these proxies, which may include elements as inexact as beneficiary age, may not be accurate enough to guarantee exclusion of Part D claims. Consequently, the OIG appears to be asserting that manufacturers may have liability for having imperfect controls, even though the current claims-processing system does not make a perfect solution available to them. The report did not identify any specific Part D claims for which coupons had in fact been used contrary to coupon terms and conditions.

The OIG recommends that CMS cooperate with industry stakeholders to improve the reliability of pharmacy claims edits, and make coupons transparent. CMS concurred with the recommendation.

OMB Clears OIG Proposed Rule on Anti-Kickback Safe Harbors, CMPs for Beneficiary Inducements & Gainsharing

The Office of Management and Budget (OMB) has cleared an HHS Office of Inspector General (OIG) proposed rule that would expand the OIG’s Medicare and state health care program fraud and abuse authorities. Specifically, on September 4, 2014, the OMB gave final regulatory clearance to an OIG proposed rule that would add new anti-kickback safe harbors to reflect statutory changes, codify the ACA’s definition of "remuneration," and add a gainsharing civil monetary penalty (CMP) regulation. The proposed rule should be published in the Federal Register in the near future.

CMS Final Rule Revises EHR Meaningful Use Timeline

The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) have issued a final rule that gives providers additional options in how they use certified electronic health record (EHR) technology (CEHRT) to meet meaningful use requirements for the 2014 EHR Incentive Program reporting period. Under the final rule, eligible providers can use the 2011 Edition CEHRT or a combination of 2011 and 2014 Edition CEHRT for an EHR reporting period in 2014. All eligible professionals, eligible hospitals, and critical access hospitals will be required to use the 2014 Edition CEHRT in 2015. Among other things, the final rule also extends meaningful use Stage 2 through 2016 for certain providers (Stage 2 meaningful use criteria focus on exchange of clinically relevant information between providers and promote patients’ secure online access to their health information). The rule also provides that Stage 3 will begin in 2017 for providers who first became meaningful EHR users in 2011 or 2012 (under Stage 3, meaningful use will include demonstrating improvement in quality of health care). 

CMS Finalizes ACA Marketplace Eligibility Redetermination/Renewal Process for 2015

On September 5, 2014, CMS is publishing a final rule that specifies additional options for annual eligibility redeterminations and renewal and re-enrollment notice requirements for qualified health plans (QHP) offered through the ACA insurance Exchange/Marketplace, beginning with annual redeterminations for coverage for plan year 2015. The rule provides an auto-enrollment process intended to provide current Marketplace consumers with a simple way to keep their 2014 QHP, although CMS encourages consumers to reevaluate their plan options and financial assistance eligibility for 2015. The rule also gives state-based Marketplaces flexible options to implement annual redetermination procedures.

HHS Revises ACA Contraception Coverage Requirements

The Obama Administration has issued two regulations addressing coverage of contraceptive services under QHPs in response to recent court rulings (in particular the Supreme Court ruling in Burwell v. Hobby Lobby Stores, Inc.) addressing certain religious objections to such coverage. First, an interim final rule provides an additional pathway for nonprofit organizations eligible for a religious accommodation to provide notice of their religious objection to covering contraceptive services. These eligible organizations are permitted to notify the Department of Health and Human Services (HHS) in writing of their religious objection to providing contraception coverage. HHS and the Department of Labor will in turn notify insurers and third party administrators so the organization’s enrollees will receive separate coverage for contraceptive services, with no additional cost to the enrollee or the employer. The interim final rule is effective August 27, 2014; comments will be accepted until October 27, 2014.

The Administration also published a related proposed rule that would extend to certain “closely-held” for-profit entities (such as Hobby Lobby) the same accommodation that is available to non-profit religious organizations with religious objections to coverage of contraceptive services. Under the proposed rule, these companies would not be required to contract, arrange, pay or refer for contraceptive coverage to which they object on religious grounds. Payments for contraceptive services provided to participants and beneficiaries in the eligible organization's plan would be provided separately by an issuer or arranged separately by a third party administrator, consistent with existing regulations for certain religious employers. Comments on the proposed rule are due by October 21, 2014.

CMS Finalizes Medicare Hospice Payment Policies for FY 2015

On August 22, 2014, CMS will publish a final rule to update the Medicare hospice wage index for FY 2015 and make other payment and policy changes. CMS estimates that hospice payments will increase by 1.4% ($230 million) in FY 2015 compared to FY 2014 under the final rule. Specifically, CMS will update the hospice per diem rates by 2.1% (reflecting a 2.9% market basket increase that is reduced by 0.8 percentage points under ACA-mandated adjustments), but this update is partially offset by a 0.7 percentage point cut resulting from the use of updated wage data and CMS’s continued phase-out of its wage index budget neutrality adjustment factor. Hospices that fail to report quality data will have their market basket update reduced by 2 percentage points.

CMS is finalizing a number of policy proposals. For instance, the final rule requires hospices to file a beneficiary Notice of Election (NOE) within five calendar days after the effective date of hospice election (compared to three days in the proposed rule). If an NOE is not filed timely, the days from the effective date of election to the date of filing the NOE would be the financial responsibility of the hospice (unless there are exceptional circumstances). Likewise, CMS is requiring hospices to file a notice of termination/revocation within five (rather than the proposed three) calendar days of a beneficiary’s discharge or revocation, unless the hospice has already filed a final claim. The rule also, among other things: requires the hospice to identify the attending physician on the election form; revises the applicability of quality reporting penalties to new hospices; requires hospices to complete their hospice cap determinations within five months after the cap year but no sooner than 3 months after the cap period and remit any overpayments; and describes the development of the CAHPS® Hospice Survey.

CMS Issues FY 2015 Medicare SNF PPS Final Rule

This post was written by Susan Edwards.

The Centers for Medicare & Medicaid Services (CMS) published the final FY 2015 Medicare skilled nursing facility (SNF) prospective payment system (PPS) rule on August 5, 2014 (Final Rule). The Final Rule largely adopts the proposals set forth in the FY 2015 proposed SNF PPS rule (Proposed Rule). CMS estimates that the Final Rule will result in a $750 million increase in aggregate payments to SNFs during FY 2015 as compared to FY 2014. The Final Rule will implement a market basket update of 2%, resulting from a market basket increase of 2.5 percentage points, reduced by the Multifactor Productivity Adjustment of 0.5 percentage points, as required by the Affordable Care Act (ACA). Below we discuss highlights of the Final Rule, including: (1) the adopted wage index update; (2) revised change of therapy (COT) Other Medicare Required Assessment (OMRA) policy; (3) revisions to the Civil Money Penalties (CMP) regulations; and (4) CMS’s responses to comments regarding the agency’s observations on therapy trends.

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CMS Finalizes Medicare IPPS/LTCH PPS Update for FY 2015

On August 22, 2014, CMS is publishing a final rule to update the Medicare acute hospital inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system (PPS) for fiscal year (FY) 2015, which begins October 1, 2014.  The following are highlights of the sweeping regulations.

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CMS Publishes Final FY 2015 Update to Medicare IRF PPS

On August 6, 2014, CMS published its final rule to update Medicare payment policies under the inpatient rehabilitation facility (IRF) PPS for FY 2015. Under the final rule, CMS expects aggregate Medicare payments to IRFs will increase by $180 million, or 2.4%, compared to 2014 levels. The standard payment conversion factor for discharges for FY 2015 is $15,198, up from $14,846 in FY 2014. The update to the conversion factor reflects a 2.9% market basket update, reduced by a -0.5% MFP adjustment and an additional -0.2 percentage point adjustment mandated by the ACA. CMS also is decreasing the outlier threshold amount for FY 2015 to $8,848 from $9,272 in FY 2014, which increases IRF PPS payments by about 0.2%. In addition, CMS adopted a freeze in the facility-level adjustment factors (e.g., adjustments for Low-Income Percentage, teaching status, and location in a rural area, if applicable) for FY 2015 and all subsequent years at FY 2014 levels while the effects of FY 2014 changes are evaluated.

In other policy areas, the final rule revises the list of impairment group codes that presumptively meet the “60 percent rule” compliance criteria; however, in response to public comments, CMS is delaying the effective date for these changes and revisions finalized in the FY 2014 IRF PPS final rule until compliance review periods beginning on or after October 1, 2015. In addition, the rule adds a therapy data item to the IRF patient assessment instrument. Beginning October 1, 2015, IRFs must record the total number of therapy minutes received and the type of therapy provided (i.e. individual, group, concurrent or co-treatment) during the first two weeks of an IRF stay. CMS also is revising the IRF Quality Reporting Program to update measures, add a reconsideration policy, and adopt a data accuracy validation policy. The final rule also discusses the transition from ICD-9-CM to ICD-10-CM for use on Medicare claims (although this transition has been put on hold temporarily as a result of the Protecting Access to Medicare Act of 2014).

CMS Issues Final Medicare Inpatient Psychiatric Facility PPS Rule for FY 2015

CMS has published a final rule that updates prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs) for FY 2015. Under the final rule, the federal per diem base rate will be increased by 2.1%, reflecting a market basket increase of 2.9%, offset by a 0.3 percentage point reduction and a productivity adjustment reduction of 0.5 percentage points (both reductions were mandated by the ACA). CMS also anticipates that the final update to the outlier fixed-dollar loss threshold amount will provide an additional 0.4% boost in overall payments to IPFs. In light of all payment policies, CMS estimates that total payments to IPFs under the final rule will increase by $120 million (2.5%) compared to FY 2014 payments. The final rule also, among other things, establishes a new methodology for updating the cost of living adjustment (consistent with the inpatient hospital methodology), expands quality measures under the IPF Quality Reporting Program, adopts coding changes related to comorbidity categories and unspecified codes, and discusses CMS’s future plans to propose an IPF-specific market basket. The final rule was published August 6, 2014.

HHS Officially Sets October 1, 2015 Date for ICD-10 Implementation

HHS has published a final rule that makes official the October 1, 2015 compliance date for the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) and the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS). HHS had previously intended to transition from ICD-9 to ICD-10 on October 1, 2014, but the Protecting Access to Medicare Act of 2014 prevents HHS from adopting ICD-10 prior to October 1, 2015.

CMS Again Extends Moratoria on Enrollment of HHAs, Ambulance Suppliers in Designated Areas

CMS has announced that it is extending for an additional 6 months its current enrollment moratoria for new ground ambulance suppliers and home health agencies (HHAs)within designated metropolitan areas. The moratoria, which affect enrollment in Medicare, Medicaid, and the Children’s Health Insurance Program, apply to new ground ambulances in the Houston and Philadelphia metropolitan areas and new HHAs in the metropolitan areas of Chicago, Fort Lauderdale, Detroit, Dallas, Houston, and Miami. CMS discusses its rationale for extending the enrollment moratoria, including the qualitative and quantitative factors suggesting a high risk of fraud, waste, or abuse, in an August 1, 2014 notice.  The extension is effective July 30, 2014.  CMS may lift the moratoria before the end of the 6-month period or announce extensions in the Federal Register notice. 

CMS Issues Proposed CY 2015 Medicare OPPS/ASC Rule

On July 14, 2014, the Centers for Medicare & Medicaid Services (CMS) published its proposed rule to update the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System rates and policies for calendar year (CY) 2015. The following are highlights of this major rulemaking:

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CMS Publishes Proposed MPFS Rule for 2015

On July 11, 2014, CMS published its proposed rule to update the Medicare physician fee schedule for CY 2015. The proposed rule reflects enactment of the Protecting Access to Medicare Act (PAMA) of 2014, which provides for a 0% update to the conversion factor (CF) for MPFS services furnished between January 1, 2015 and March 31, 2015. In the Proposed Rule, CMS estimates that with the application of a budget neutrality adjustment, the CF for the first quarter of 2015 would be $35.7977 (compared to $35.8228 in 2014). Under PAMA, the CF will be adjusted on April 1, 2015 according to the Sustainable Growth Rate (SGR) formula unless Congress takes additional legislative action. CMS does not speculate on the CF that will be applicable April 1, 2015 through December 31, 2015, but CMS previously estimated that the SGR would result in about a 20.9% cut in MPFS payments for 2015 if Congress does not again intervene. There is an expectation that Congress eventually will override this payment cut, but the timing and extent of any such relief cannot be assured at this time. Other key provision in the proposed rule include the following:

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CMS Proposes ESRD PPS Update for CY 2015

On July 11, 2014, CMS published a proposed rule to update the Medicare end-stage renal disease (ESRD) PPS for CY 2015, which CMS anticipates would increase total payments to all ESRD facilities by 0.3% compared to CY 2014. While CMS projects that the ESRD market basket update, as adjusted for MFP, would have been 1.6%, the “Protecting Access to Medicare Act of 2014” (PAMA) sets the CY 2015 ESRD payment update at 0.0 percent. After applying a proposed wage index budget-neutrality adjustment factor, CMS estimates that the CY 2015 ESRD PPS base rate would be $239.33 under the proposed rule. The proposed rule also would, among other things: rebase the ESRD bundled market basket using 2012 data; update outlier Medicare Allowable Payment (MAP) and fixed dollar loss amounts (which will increase payments to ESRD facilities for beneficiaries requiring higher resource utilization); revise the market basket measures; update the labor -related share value with a two-year transition; clarify the eligibility criteria for the low volume payment adjustment ; and implement a PAMA provision providing that payment for ESRD-related oral-only drugs will not be made under the ESRD PPS prior to January 1, 2024. CMS also proposes updates to the ESRD Quality Incentive Program (QIP) for payment years 2017 and 2018. Finally, the proposed rule would make significant changes to Medicare reimbursement policy for DME, prosthetics, orthotics, and supplies (DMEPOS). CMS will accept comments on the proposed rule until September 2, 2014.

Proposed ACA Eligibility Redetermination/Renewal Process for 2015

HHS has issued a proposed rule that would specify additional options for annual eligibility redeterminations and renewal and re-enrollment notice requirements for qualified health plans offered through the ACA insurance Exchange/Marketplace, beginning with annual redeterminations for coverage for plan year 2015.  Comments are due July 28, 2014.

OIG Seeks Input on Potential Revisions to its Permissive Exclusion Criteria

The OIG published a notice July 11, 2014 announcing that it is considering revising its nonbinding criteria, established in 1997, outlining the circumstances under which the OIG may exercise its permissive authority under Section 1128(b)(7) of the Social Security Act to exclude an individual or entity from participation in the federal health care programs for engaging in conduct described in sections 1128A and 1128B of the Act (e.g., submitting or causing the submission of false or fraudulent claims or soliciting or paying kickbacks in violation of the Federal Anti-Kickback Statute). Since 1997, OIG has used these criteria in False Claims Act cases and administrative matters to evaluate whether to impose a permissive exclusion or release this authority in exchange for the defendant’s entering into a Corporate Integrity Agreement with OIG. The OIG suggests that “updated guidance could better reflect the state of the health care industry today, including the changes in legal requirements and the emergence of the health care compliance industry.” The OIG is particularly interested in input on: (1) whether there should be differences in the criteria for individuals and entities and (2) whether and how to consider a defendant's existing compliance program. The OIG will accept comments through September 9, 2014. After reviewing comments, the OIG will decide whether and how to revise its non-binding exclusion criteria.

Proposed ACA Eligibility Redetermination/Renewal Process for 2015

HHS has issued a proposed rule that would specify additional options for annual eligibility redeterminations and renewal and re-enrollment notice requirements for qualified health plans offered through the ACA insurance Exchange/Marketplace, beginning with annual redeterminations for coverage for plan year 2015.  Comments are due July 28, 2014.

CMS Proposes Major Changes to Medicare DMEPOS Payment/Coverage Policy Inside/Outside of Competitive Bidding Areas

On July 2, 2014, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule that would make a series of significant changes to Medicare coverage and payment policies for durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS). Notably, the proposed rule would establish a methodology for adjusting Medicare DMEPOS fee schedule payment amounts across the country using information from the Medicare DMEPOS Competitive Bidding Program (CBP) – which CMS estimates would cut Medicare DMEPOS reimbursement by more than $7 billion in FYs 2016 through 2020. The proposed rule also would: test the use of bundled monthly payment amounts for DME and enteral nutrition under the CBP; modify CBP change of ownership (CHOW) and termination of contract rules; clarify qualifications for providing custom fitting services for orthotics; and revise Medicare hearing aid coverage policy. These provisions, which were part of a broader proposed rule that would also update the Medicare end-stage renal disease prospective payment system for 2015, are summarized in our Client Alert.

CMS Proposes Changes to Sunshine Act "Open Payments" Regulations in 2015 Medicare Physician Fee Schedule Rule

This post was written by Elizabeth Carder-Thompson, Katie C. Pawlitz, and Nancy E. Bonifant.

Today the Centers for Medicare & Medicaid Services (CMS) issued an advance copy of the CY 2015 Medicare Physician Fee Schedule (PFS) proposed rule, which includes certain changes to the regulations implementing the Physician Payment Sunshine Act, also known as the Open Payments program. These proposed changes come just three days after the inaugural deadline for applicable manufacturers and group purchasing organizations (GPOs) to report to CMS detailed information regarding payments and transfers of value made to physicians and teaching hospitals, as well as physician ownership information.

As previously reported, the Physician Payment Sunshine Act and related regulations require pharmaceutical and medical device manufacturers and GPOs to register with and submit to CMS data on their financial relationships with physicians and teaching hospitals. This financial data will be made publicly available on the CMS Open Payments website.

In the PFS proposed rule, CMS proposes the following changes to the Physician Payment Sunshine Act regulations:

  • Deleting the definition of “covered device” as duplicative of the definition of “covered drug, device, biological or medical supply”
  • Deleting the reporting exclusion for payments made to speakers at accredited continuing medical education events when certain requirements are met. Although CMS is deleting this express exclusion, it notes that such payments may still be excluded generally from reporting under the separate exclusion for indirect payments, which applies in those instances in which the applicable manufacturer is unaware of the identity of the covered recipient. In other words, the practical impact of this change may not be significant in the long run.
  • Requiring the reporting of the marketed name of the drug, device, biological, or medical supply related to the payment being reported. Previously, CMS finalized that for drugs and biologicals, manufacturers must report the market name of a related product, but that for devices and medial supplies, manufacturers could report either the name under which the product is marketed or the general therapeutic area or product category associated with the device or medical supply.
  • Requiring manufacturers to report stocks, stock options or any other ownership interest as distinct categories.

The proposed rule will be published in the Federal Register on July 11, 2014, and comments are due to CMS by September 2, 2014.

Older Entries

July 1, 2014 — CMS Proposes 0.3% Cut in Medicare Home Health PPS Rates for CY 2015

June 27, 2014 — CMS Planning Changes to Medicare Shared Savings Program/Accountable Care Organization (ACO) Rules

June 24, 2014 — Medicare Payment Adjustments for Low-Volume Hospitals and Medicare-Dependent Hospitals

June 24, 2014 — HHS Issues Spring 2014 Semiannual Regulatory Agenda

June 24, 2014 — Obama Administration Finalizes Employment Orientation Limit Applicable to ACA Health Coverage Waiting Period

June 2, 2014 — CMS Finalizes Updates to Medicare Advantage/Part D Policies for 2015

June 2, 2014 — CMS Finalizes ACA Exchange, Insurance Market Standards for 2015 and Beyond

May 30, 2014 — CMS Formally Proposes Modified Electronic Health Record (EHR) Meaningful Use Timeline

May 22, 2014 — CMS Proposes Medicare Prior Authorization Process for DMEPOS Subject to "Unnecessary Utilization"

May 20, 2014 — OIG Proposed Rule Would Expand Civil Monetary Penalty Authority

May 16, 2014 — HHS OIG Proposes Expansion of Exclusion Authorities

May 16, 2014 — Another OIG Fraud Rule in the Pipeline: Anti-kickback Safe Harbors, CMPs for Beneficiary Inducements, Gainsharing

May 15, 2014 — CMS Adopts Final Rule to Reduce Provider Regulatory Burdens

May 15, 2014 — CMS Proposes Medicare Hospice Payment Policies for FY 2015

May 15, 2014 — CMS Proposes FY 2015 Update to Inpatient Psychiatric Facility PPS

May 15, 2014 — CMS Adopts PPS for Federally Qualified Health Centers (FQHCs), Amends CLIA Rules

May 14, 2014 — CMS Proposes FY 2015 Update to Medicare IRF PPS

May 14, 2014 — OIG Proposes Rules to Expand Exclusion, CMP Authorities

May 13, 2014 — CMS Invites Comments on Sunshine Act "Open Payments" Dispute Resolution/Corrections Process

May 13, 2014 — CMS Issues FY 2015 Medicare SNF PPS Proposed Rule

May 8, 2014 — CMS Streamlines Medicare Requirements for Imaging Services Performed in ASCs and Hospital Radiopharmaceutical Preparation

May 1, 2014 — CMS Releases Proposed Medicare Inpatient PPS/LTCH Update for FY 2015

April 28, 2014 — Proposed FY 2015 Medicare Payment Rules in the Pipeline

April 28, 2014 — CMS Proposes Updated Life Safety Code for Health Care Facilities

April 8, 2014 — RACs Correct $2.4 Billion in Medicare Claims in FY 2012

April 8, 2014 — CMS Announces System to Collect Hospice Care Data Beginning July 1, 2014

March 24, 2014 — Obama Administration Continues to Update ACA Insurance Exchange and Health Plan Regulations

March 20, 2014 — CMS Rule Increases FY 2014 Medicare Payments for Low-Volume Hospitals

March 19, 2014 — CMS Rule Requires Qualified Health Plans to Accept Certain Third-Party Premium Payments

March 4, 2014 — ONC Proposes Updated Electronic Health Record (EHR) Certification Criteria for 2015

March 4, 2014 — Preliminary FY 2014 DSH Allotments Announced

March 3, 2014 — CMS Takes First Steps to Cut Medicare DMEPOS Fees Based on Competitive Bidding Prices

March 3, 2014 — Obama Administration Issues ACA Health Coverage Waiting Period Regulations

February 18, 2014 — CMS Extends and Expands Moratoria on Enrollment of Home Health Agency, Ambulance Suppliers in Designated Areas

February 17, 2014 — CMS Seeks New Participants for Bundled Payments for Care Improvement Initiative

February 17, 2014 — Final HIPAA Rule Gives Patients Right to Access Test Results Directly from Labs

February 11, 2014 — CMS Invites Proposals for Frontier Community Health Integration Demonstration

January 30, 2014 — CMS Finalizes Rule to Strengthen Home- and Community-Based Services (HCBS) Options

January 30, 2014 — HHS Publishes FY 2015 FMAP Amounts

January 29, 2014 — Reed Smith Client Alert: CMS/OIG Extend Protections for Electronic Health Record Donations

January 20, 2014 — FDA Seeks Comments on Drug Company Social Media Guidance

January 8, 2014 — CMS Proposes Updates to Medicare Advantage/Part D Policies for 2015

January 7, 2014 — CMS Proposes Emergency Preparedness Requirements for Medicare/Medicaid Providers

January 7, 2014 — CMS, FDA Extend Pilot Program for Parallel Review of Medical Products

January 7, 2014 — OIG Seeks Anti-Kickback Safe Harbor, Fraud-Alert Topic Proposals

January 7, 2014 — HHS Proposes HIPAA Amendments Addressing Gun Background Checks

January 7, 2014 — CMS Proposes 2015 Funding Methodology for ACA Basic Health Program

January 7, 2014 — CMS Issues Formally Updates 2014 Health Exchange Enrollment Deadlines

January 6, 2014 — HHS Proposed Rule on Health Plan Certification of Compliance Requirements

January 6, 2014 — CMS Seeks Comments on MSP CMP Policies, Appeals Process

December 27, 2013 — Final Rules Issued Extending Protections of Electronic Health Record Donations

December 10, 2013 — CMS Issues Final Medicare OPPS, ASC Policies for 2014

December 10, 2013 — CMS Updates Medicare Physician Fee Schedule, Other Part B Policies for CY 2014

December 10, 2013 — CMS Finalizes 2014 ESRD PPS Rates; Phases in ESRD Drug Utilization Cut

December 10, 2013 — CMS Proposed Rule on ACA Benefit and Payment Parameters for 2015

December 10, 2013 — CMS Boosts Provider Enrollment Fee for 2014

December 3, 2013 — CMS Adopts Changes to Medicare Payment, Coverage Rules for DMEPOS

November 25, 2013 — Medicare Home Health PPS Rates Cut 1.05% Under Final 2014 Rule

November 25, 2013 — CMS Seeks Input on Quality Ratings for ACA Exchange Plans

November 14, 2013 — CMS Invites Nominees for Members of Advisory Panel on Hospital Outpatient Payment

November 14, 2013 — HHS Corrects March 2013 ACA Benefit, Payment Parameter Rules

November 13, 2013 — Obama Administration Publishes Final Mental Health/Substance Abuse Parity Rule

October 30, 2013 — CMS Finalizes ACA Exchange Program Integrity & Financial Oversight Standards

October 30, 2013 — CMS Releases Medicare Deductible, Coinsurance Amounts for 2014

October 30, 2013 — Nominees Invited for PCORI Physician Representative

October 30, 2013 — CMS Warns of Delay in Final CY 2014 Medicare Rules

October 29, 2013 — CMS Finalizes Medicare Conditions of Participation for Community Mental Health Centers

October 10, 2013 — HHS Proposes ACA Basic Health Program Regulations

October 10, 2013 — CMS Final Rule Refines FY 2014 DSH Payment Calculations

October 10, 2013 — CMS Proposes Rules for Medicare FQHC PPS, CLIA Amendments

October 9, 2013 — CMS Announces 2014 Amounts in Controversy Threshold Amounts for Medicare Appeals

October 9, 2013 — CMS Corrects FY 2014 Medicare Payment Rules

September 17, 2013 — HHS Seeks Comments on Draft National Action Plan for Adverse Drug Event Prevention

September 17, 2013 — OIG Call for Medicare Part B Drug Rebates Rejected by CMS

September 17, 2013 — CMS Finalizes ACA Exchange/Qualified Health Plan Financial Integrity and Oversight Standards

September 16, 2013 — CMS Releases ACA Medicaid DSH Funding Final Rule

September 16, 2013 — HHS Invites Suggestions for Streamlining Regulations

September 16, 2013 — OIG Report Examines Critical Access Hospital Qualifications

September 16, 2013 — HHS Draft Strategic Plan Outlines Department Goals

September 16, 2013 — OIG Focuses on Improper Medicare Diabetes Test Strip Payments

September 16, 2013 — OIG Reports Point States to Potential Medicaid DMEPOS Savings

September 16, 2013 — OIG Seeks Improvements to RAC Program, Enhanced CMS Efforts to Stop Improper Medicare Payments

September 16, 2013 — OIG Urges CMS Action on Medicaid Drug Pricing Changes in Preparation of ACA Enrollment Expansion

September 11, 2013 — CMS Issues Technical Corrections to CY 2014 Proposed OPPS/ASC Rule

September 3, 2013 — Recent Updates to the Hospital Readmissions Reduction Program

August 28, 2013 — CMS Finalizes FY 2014 Medicare IPPS, LTCH Rates

August 28, 2013 — CMS Issues Final FY 2014 Medicare Inpatient Rehabilitation Facility (IRF) Rule

August 27, 2013 — HHS Seeks Comments on ACA Provision Preventing Discrimination in Certain Health Programs, Activities

August 27, 2013 — CMS Publishes Final FY 2014 Medicare SNF PPS Rates, Policies

August 27, 2013 — CMS Finalizes Hospice Policies, Rates for FY 2014

August 27, 2013 — CMS Issues Final FY 2014 Inpatient Psychiatric Facility PPS Rates

August 27, 2013 — CMS Suspends Medicaid NARP Drug Data Collection

August 27, 2013 — Medicare Billing For Cancelled Elective Surgeries

August 27, 2013 — OIG Questions Hospital Use of Observational Stays

August 27, 2013 — OIG Examines Clinical Trial Data and Safety Monitoring Boards

August 27, 2013 — Medicaid Disproportionate Share Hospital Allotments

August 12, 2013 — CMS Revises Medicare National Coverage Determination Process, Eases Path to Discontinue Outdated Coverage Policies

August 2, 2013 — FDA Proposes New Rule to Exercise its Administrative Detention Authority for Drugs

July 29, 2013 — CMS Issues Proposed OPPS, ASC Policies for 2014, Including Expanded OPPS Packaging Proposal

July 29, 2013 — CMS Announces First Temporary Moratoria on HHA, Ambulance Supplier Enrollment in High-Risk Areas under ACA Authority